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RSS FeedPosted by Michael Wonder on 03 Aug 2021
US FDA grants priority review to Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
3 August 2021 - Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme. ...
Posted by Michael Wonder on 03 Aug 2021
GSK files for licensure of MMR vaccine in the US
2 August 2021 - GSK seeks US approval of Priorix vaccine licensed in more than 100 countries. ...
Posted by Michael Wonder on 03 Aug 2021
Celltrion Healthcare announces acceptance and priority review by Health Canada of New Drug Submission for its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59)
2 August 2021 - Celltrion Healthcare Canada remains committed to working closely with Health Canada to make its monoclonal antibody treatment ...
Posted by Michael Wonder on 03 Aug 2021
Mustang Bio receives European Medicines Agency PRIME designation for MB-107 to treat X-linked severe combined immunodeficiency in newly diagnosed infants
2 August 2021 - Mustang Bio today announced that the EMA has granted Priority Medicines designation to MB-107, its lentiviral ...
Posted by Michael Wonder on 03 Aug 2021
Amicus Therapeutics announces European Commission approval of Galafold (migalastat) for adolescents with Fabry disease
2 August 2021 - Galafold is the first and only oral therapy approved in the EU for the long-term treatment of ...
Posted by Michael Wonder on 02 Aug 2021
FDA’s Pazdur challenges attack on accelerated approval program
2 August 2021 - In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill ...
Posted by Michael Wonder on 02 Aug 2021
Pfizer, Moderna raise prices of COVID-19 coronavirus vaccines for European Union
1 August 2021 - What’s the best way to get more people vaccinated against COVID-19 to try to end the ...
Posted by Michael Wonder on 02 Aug 2021
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
30 July 2021 - Approval is based on Phase 3 results from the CheckMate-577 trial. ...
Posted by Michael Wonder on 02 Aug 2021
Alkermes receives FDA fast track designation for nemvaleukin alfa for the treatment of mucosal melanoma
2 August 2021 - Alkermes today announced that the U.S. FDA has granted fast track designation to nemvaleukin alfa, the ...
Posted by Michael Wonder on 02 Aug 2021
Working towards harmonised access to clinical trial data across European drug regulatory agencies
31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...
Posted by Michael Wonder on 02 Aug 2021
GSK receives authorization under Health Canada's Interim Order for sotrovimab for Injection to treat COVID-19 in high-risk adults and adolescents
30 July 2021 - GSK announced today that Health Canada has granted an Interim Order Authorisation for sotrovimab for Injection (sotrovimab, ...
Posted by Michael Wonder on 02 Aug 2021
Benlysta now approved in Canada in addition to standard therapy for treatment of active lupus nephritis in adult patients
30 July 2021 - Benlysta (belimumab) has been approved in Canada for the treatment of active lupus nephritis in adult ...
Posted by Michael Wonder on 02 Aug 2021
Six month countdown to go live for the Clinical Trials Information System
2 August 2021 - The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and ...
Posted by Michael Wonder on 02 Aug 2021
Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus
2 August 2021 - Saphnelo is a first in class type I interferon receptor antibody and the only new medicine ...
Posted by Michael Wonder on 02 Aug 2021
ATAGI statement regarding vaccination of adolescents aged 12–15 years
2 August 2021 - Following the recent approval by the TGA for the provisional registration of the Comirnaty (Pfizer) COVID-19 vaccine ...